Promepla
Country not established
- Devices
- 262
What Promepla makes
Promepla manufactures ureteral catheters, including soft polymeric stents like the RocaJJ and LumaFlex series, designed for urinary drainage and obstruction management. Their portfolio also includes single-use biliary and urinary stone retrieval baskets, endoscopic irrigation/aspiration systems, and specialized tubing sets for surgical procedures such as hysteroscopy and transurethral resection. Guide wires, irrigation probes, and general-purpose fluid transfer sets are also part of their product line, catering to urological and gynecological applications.
The company’s devices are regulated under FDA classifications, with most falling into Class I or Class II categories. These products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, ensuring compliance with U.S. medical device regulations. Promepla operates from the United States, adhering to domestic regulatory requirements for their distributed products.
Catalogue
Search and filter all 262 devicesShowing 1-50 of 262
Company details
- DUNS number
- 401020409
- customer@rocamed.eu
- Phone
- +37797984232
Frequently asked questions
How many devices does Promepla have in the registry?
The registry currently lists 262 devices for Promepla. Devices recorded under merged duplicate company entries are counted once.
Which registries list Promepla's devices?
Among its 50 most recently registered devices, Promepla has devices listed in EUDAMED (2 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Promepla's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Promepla's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Promepla in the registry?
The most recently registered devices listed for Promepla include Irrigation Tube OSG03499ST35, RocaJJ Soft Stent - Ø 8 Fr - Length 26cm ROJG9826ST, Gynecology - 2 way Hysteroscopy set 2 spike with aspiration tubing SOHY9202ST12 and ENDOFLOW II - PROBES - 6 holes diam 5 inch OJG05DST12.